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Medicinal Products Availability

Dáil Éireann Debate, Tuesday - 6 November 2018

Tuesday, 6 November 2018

Ceisteanna (688)

Charlie McConalogue

Ceist:

688. Deputy Charlie McConalogue asked the Minister for Health further to Parliamentary Question No. 179 of 27 June 2018, the status of the HSE’s investigations on the provision of a drug (details supplied); and if he will make a statement on the matter. [45507/18]

Amharc ar fhreagra

Freagraí scríofa

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on medicine reimbursement. As Minister for Health, I do not have any statutory function in relation to the reimbursement of medicines.

In line with the 2013 Act, if a company would like a product to be reimbursed in the community drug schemes, it must apply to the HSE to have the product added to the reimbursement list.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, including the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments may be multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.

The NCPE completed an HTA on 29 August 2018 for ocrelizumab for the treatment of relapsing forms of multiple sclerosis. It recommended that ocrelizumab not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.

On 4 October 2018, the NCPE completed its assessment of ocrelizumab for the treatment of early primary progressive multiple sclerosis. It did not recommend reimbursement for this indication.

The HSE has advised that it is in discussion with the applicant in relation to the reimbursement of ocrelizumab. Any decision it makes on reimbursement will be taken in the context of expert advice received and the statutory criteria set out in the 2013 Act.

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